Clinical Research Coordinator C

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Posted Job Title

Clinical Research Coordinator C (Department of Ophthalmology)

Job Profile Title

Clinical Research Coordinator C

Job Description Summary

This position will be a resource for best practices of managing major clinical trials. The coordinator will provide guidance to both study trials and device trials. The incumbent will be a liaison to departmental interaction such as the investigational team, the nursing units and sponsor. They will be a resource to other members of the team and will oversee the implementation of new clinical trials. Will review all new trials to help identify the challenges and opportunities discovered. Will problem-solve the challenges to implement a plan of action. Work with the regulatory manager to ensure that submissions to the IRB are completed in a timely manner.

This position will be a resource for best practices of managing major clinical trials. The coordinator will provide guidance to both study trials and device trials. The incumbent will be a liaison to departmental interaction such as the investigational team, the nursing units and sponsor. He/She will be a resource to other members of the team and will oversee the implementation of new clinical trials. Will review all new trials to help identify the challenges to implement a plan of action; and opportunities discovered. Will problem-solve the challenges to implement a plan of action; will work with the regulatory manager to ensure that submissions to the IRB are completed in a timely manner. Will supervise the execution of the trial with the staff to ensure adherence to the protocol is followed and will audit the trials for compliance and enrollment which include a review of the data entry for accuracy and completeness and adverse event management. The coordinator will take an active role in preparation of trial audits and inspection. The coordinator will take a lead role supervising any inspection that takes place with the trials. S/he will provide monthly updates to the research team and the director.

This roles requires a combination of both comprehensive clinical research coordination including ophthalmic clinical diagnostic testing. The position reports to the Project Manager of Ophthalmology Clinical Research.

**Job Description**:
Job Responsibilities
- Coordinate Phase I-IV clinical trials
- Recruit, consent and screen patients according to protocol
- Schedule patient visits and any necessary testing. Monitor patients per protocol requirements and ensure adherence to protocol requirements
- Organize and maintain all required documentation
- including source documentation, case report forms, and research charts. Collect, review and report study data, Complete case report forms and resolve data queries
- Process and ship study specimens including blood, urine and tissue samples
- Participate in the initiation, monitoring, audit, and close-out visits. Participate in study team meetings disease site group meetings, and ongoing protocol training/compliance meetings
- Develop/maintain study specific case report forms and source document tools
- Participate in the coordination of Phase I-IV clinical trials (10% Essential: 1),Prepare and process all regulatory documentation through the IRB, CTSRMC, FDA and all other appl